Regulatory & Quality Compliance

ISO Certifications & Quality Assurances

Reddrop Healthcare Pvt. Ltd. • "Preserve every drop" • Trans Yamuna Colony, Agra, UP, India

Primary Quality Framework

ISO 13485:2016 Quality Management Certification

ISO 13485:2016 is the internationally recognized benchmark for quality management systems in the medical device industry. Reddrop Healthcare Pvt. Ltd. maintains strict adherence to ISO 13485 across manufacturing, calibration, cold-chain maintenance, and wholesale distribution in Agra.

Certificate StandardISO 13485:2016 Medical Devices

Manufacturing & Supply ScopeBlood Bank Equipment, Cold-Chain & Diagnostics

Verified Compliance

Valid ISO Audit Standard

Official certificate documents supplied for government hospital tenders and institutional compliance checks.

CDSCO Approved Products

All diagnostic test kits, blood bags, and collection machines manufactured and supplied by Reddrop Healthcare carry active regulatory compliance under CDSCO.

Controlled Cold-Chain Standards

Our +4°C Blood Bank Refrigerators and -40°C/-80°C Ultra-Low Freezers are certified with digital temperature loggers and multi-alarm safety mechanisms.

Batch Calibration & COA Reports

Every machine dispatch includes factory calibration reports, electrical safety verification, and Certificate of Analysis for hospital tender compliance.

Need Official ISO or Quality Documentation?

Request certificate copies or tender compliance documentation directly from our team.